Catalog Number

DI-1406A

Brand Name

Coulmed

Version/Model Number

DI-1406A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

7c897817-8d30-4762-970d-4ed5f1100d16

Public Version Date

May 18, 2021

Public Version Number

4

DI Record Publish Date

May 28, 2019

Package DI Number

00850003355337

Quantity per Package

12

Contains DI Package

00850003355320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-